Modern Needs
Yajat G -
Hi everyone,
In this blog post, I will cover a little more about my literature review and some of the experiences I have had over the past few days regarding the project. On Thursday, I had the privilege to talk to a specialist in clinical trial organization, John Spanias. He gave me some insight into the industry of clinical trials and how diversity was a key factor. He also mentioned that the inclusion of diverse groups has only recently risen, and even just a decade or two ago, diversity was not an important factor in clinical trials. That information connects very well to my data as it started in 1994 with very little diversity and has mostly been on an upward trend. One clear thing, though, is that the industry demands higher levels of diversity for more accurate results. Although there are no exact proportions of what the FDA or NIH requires, The Food and Drug Omnibus Reform Act (FDORA) includes clinical trial diversity and modernization provisions. These provisions require that sponsors of certain clinical studies submit Diversity Action Plans to the FDA. The purpose is to improve the enrollment of populations that have historically been underrepresented in clinical studies of drugs. This law gives the FDA the authority to require that sponsors submit Diversity Action Plans that specify their enrollment goals. Even with these stricter diversity rules, many clinical trials with low levels of diversity are still approved. Still, as I mentioned in my last blog, that doesn’t necessarily mean market success due to a lack of compliance from insurance companies. The next step society has to take to streamline and advance the field of medicine is to become more diverse, regardless of the extra time and money it may need.